Novartis’ Arzerra gains CLL approval

Novartis and Genmab’s Arzerra has been approved in the US a new chronic lymphocytic leukaemia indication.

The new FDA approval allows the drug to be used with a new combination of drugs, when the disease has relapsed, helping it compete in a crowded market place.

The FDA decision follows a disappointment in June, when Europe’s CHMP regulatory committee rejected Arzerra (ofatumumab) as a maintenance therapy for CLL, although the FDA did approve the drug in long-term use for CLL early this year.

The new use could provide a welcome boost as Novartis attempts to increase sales, after it acquired rights to Arzerra following its asset swap deal with GlaxoSmithKline last year.

Arzerra has failed to set the CLL market alight since its launch in 2009, where it has struggled to make headway against Roche’s MabThera/Rituxan (rituximab).

Genmab said in half-year results that Novartis’ sales of Arzerra in the first half of 2016 were $24.8 million.

It is also being developed in non-Hodgkin’s lymphoma, with a filing scheduled in 2018. A phase 3 trial in relapsing multiple sclerosis will begin recruiting patients in the coming weeks.

The FDA approved the CLL new use after granting a Priority Review back in May.

Approval was based on results from the phase 3 COMPLEMENT 2 study evaluating Arzerra in combination with fludarabine and cyclophosphamide (FC), versus FC alone, in patients with relapsed CLL.

This is the fourth US indication for Arzerra, a human monoclonal antibody targetting the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

Genmab and Novartis are also developing the drug as a treatment for multiple sclerosis. The companies believe it can be the best-in-class among B-cell targeting treatments, and enrollment of patients for a phase 3 trial begin this month. However Roche has a rival treatment in the class, ocrelizumab, which looks set to gain approval in late 2016 or early 2017.